FDA Enforcement
Class II
Ongoing
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
Recall: Z-1183-2024
·
Reported March 6, 2024
Enforcement
- Recall Number
- Z-1183-2024
- Event ID
- 93857
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Zyno Medical LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 6, 2024
- Initiation Date
- December 20, 2023
- Classification Date
- February 23, 2024
- Address
- 177 Pine St, Natick, MA, 01760-1331, United States
Description
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
Reason
When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death
Code Info
UDI: 00814371020037 software version 5.2.05
Distribution
Nationwide
Quantity
574 units